The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Vsi Straitset Micro-introducer Kit.
| Device ID | K161336 |
| 510k Number | K161336 |
| Device Name: | VSI StraitSet Micro-introducer Kit |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT NORTH Minneapolis, MN 55369 |
| Contact | Adam Ettl |
| Correspondent | Adam Ettl VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT NORTH Minneapolis, MN 55369 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-13 |
| Decision Date | 2016-08-11 |
| Summary: | summary |